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The 2.3% tax on medical devices is a thing of the past. Now, Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), has revealed to BioWorld that the supporters of the Affordable Care Act (ACA) saw the tax as little more than “a spreadsheet exercise” in financing the more costly elements of the legislation.
The controversy over the use of paclitaxel-bearing devices in the femoropopliteal arteries is far from over. Now, a new medical journal article makes a similar claim about mortality in connection with the use of these devices in the infrapopliteal arteries, threatening once again to take a bite out of utilization. The first study to generate controversy over paclitaxel in drug-coated balloons and drug-eluting stents appeared in the medical literature toward the end of 2018, and a flurry of activity ensued.
A new report by the Congressional Research Service (CRS) revives the question of U.S. FDA regulation of lab-developed tests (LDTs). However, attorney Jeffrey Shapiro, of Washington-based Hyman Phelps & McNamara PC, told BioWorld that the agency is no longer in a position to unilaterally impose a regulatory regime on LDTs, and that there is little likelihood that any enabling legislation will pass until at least 2021.
A new study of 30 patients has demonstrated that embolization coils adequately seal the left atrial appendage after implant of LAA closure devices, but the author of an accompanying editorial expressed concerns regarding the absence of understanding of both the causes and implications of these leaks.
Device makers only can watch when cardiologists grapple with federal agency officials over device utilization. However, cardiologists are punching back hard against a rule used to judge whether a coronary artery stent is appropriately used, thus ensuring these devices won’t suffer a significant drop in utilization.
The U.S. Supreme Court has declined to hear the case of Athena v. Mayo, which many hoped would ease the patent subject matter eligibility problem. This outcome leaves Congress and the Court of Appeals for the Federal Circuit as the only likely sources of resolution for the problem, but there is skepticism as to whether either of these parties is both willing and able to overcome the impasse.
Jenavalve Technology Inc., of Irvine, Calif., has won an FDA breakthrough device designation for its namesake transcatheter aortic valve replacement device, but Jenavalve said it will file for a humanitarian device exemption in the second half of 2020, suggesting that the device won’t be commercially available for at least another year.
SAN FRANCISCO – Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod...
SANTA CLARA, Calif. – Peter Thiel is not a fan of incremental science. The high-profile venture capital investor, who invests across technology and the life...
China announced Jan. 17 which further pharmaceutical companies it will buy from under its centralized procurement program that seeks the lowest prices. The price...
In response to the emergence of a new coronavirus seen recently in China, and now America, Novavax Inc. has initiated development of a vaccine candidate, the...
It is equally fair to say that lung cancer treatment has come a long way, and that it has a long way to go. Speaking at a joint conference by the International...
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